Phase 2
Completed N=49
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
Source: ClinicalTrials.gov NCT02536313 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12) — 100.0; 96.0 percentage of particpants
Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12) |
100.0; 96.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event |
0; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
100.0; 96.0; 100.0; 96.0 | — |
| SECONDARY Percentage of Participants With HCV RNA < LLOQ on Treatment |
54.2; 40; 79.2; 60.0; 100; 92.0 | — |
| SECONDARY HCV RNA Change From Baseline/Day 1 Through Week 12 |
-4.63; -4.53; -4.97; -4.95; -5.10; -5.14 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 4.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Individuals with chronic HCV genotype 1 infection
- Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
- Absence of cirrhosis or presence of compensated cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or sexually active male
Key Exclusion Criteria
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or a nursing female
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02536313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.